Recalls / Class II
Class IID-1628-2020
Product
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
- Affected lot / code info
- Lot 8A11A exp 12/20
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 25,843 bottles
- Distribution pattern
- Nationwide in CA, IN, VA, NJ, NY, RI, FL, TX, MO, PA, MI, AL, TN, SC
Timeline
- Recall initiated
- 2020-09-03
- FDA classified
- 2020-09-30
- Posted by FDA
- 2020-10-07
- Terminated
- 2022-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1628-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.